Hogan Lovells Publications | 29 September 2017

CDRH's "Critical to Quality" PMA pilot program opens to applicants today

The U.S. Food and Drug Administration’s recently announced voluntary Premarket Approval Application (PMA) “Critical to Quality” pilot program opens to applicants today.

The voluntary PMA pilot program will run from September 29, 2017, to December 31, 2018, or until a total of nine PMA applicants have been enrolled. The program will engage these PMA applicants to identify and define device characteristics that reflect quality in device design and manufacturing.

Applicants accepted into the pilot program will be allowed to forego the standard PMA preapproval inspection and, in its place, undergo a postmarket inspection focusing on the applicant’s implementation of the “critical to quality” (CtQ) controls identified in the approved PMA. For established companies with a positive inspection history, participation in the pilot program may offer the benefit of avoiding a pre-PMA inspection, which also may result in faster approval.

Click here to learn more.

Download PDF Back To Listing